Senior Development Scientist

Catalent

5d•Onsite

About The Position

The Senior Development Scientist leads and supports formulation and process development activities while serving as a primary point of contact with the client regarding pharmaceutical development and clinical manufacturing project related activities. The Senior Development Scientist is responsible for supporting these activities in the areas of supervision, process development, clinical trial batch manufacturing, packing and documentation. Position Summary This position is 100% on-site at the Greenville site. Catalent’s Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development. The Senior Development Scientist will independently design, coordinate, and execute all product development activities including material characterization, excipient selection, prototype manufacture, equipment selection, generation of batch records, scale-up, QbD, and registration batch activities

Requirements

Bachelor’s degree in pharmaceutical science, chemistry, engineering or related science with at least ten years of industrial pharmaceutical experience required or;
Master’s degree in pharmaceutical science, chemistry, or related science with at least nine years of industrial pharmaceutical experience required or;
Ph.D. in Pharmaceutical Science or related field or Pharm.D. with at least seven years of industrial product development experience required.
Some exposure to hazardous chemicals and other active chemical ingredients.
Capacity to handle and manipulate objects using hands and arms.
Ability to occasionally lift items in excess of 50 pounds.
This position requires that a respirator be worn for your safety, and as such, employment is contingent upon being able to complete a medical evaluation with satisfactory results. The medical evaluation is conducted via an external vendor assigned by Catalent.

Responsibilities

Work closely with analytical scientists, project management, quality, and commercial operations to ensure that formulation and process development are appropriate and timely.
Write all the required documentations such as batch records, product development reports, risk assessments, and campaign summaries.
Communicate effectively with internal staff, clients, and external vendors.
Responsible for GMP compliance in formulation and process development.
Support and contribute to qualification of facility and equipment.
Coordinate with logistics and scheduling groups to help ensure that an adequate inventory of raw materials is maintained at all times.
Maintain competence and training documentation for relevant equipment and processes.
All other duties as assigned.